BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENT SYSTEM

    MDR report key: 15509449 · Received September 30, 2022

    Report

    Report Number
    3001845648-2022-00677
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Date of Event
    March 28, 2022
    Report Date
    December 28, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QIJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: (B)(6). PMA/510(K): D362689. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: QIJ. PMA/510(K): D362689. DEVICE EVALUATION: THE ECHO PPG DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: N/A. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION, ALL ECHO-PPG DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS THE LOT NUMBER IS UNKNOWN A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE FOR ANY DAMAGE: "VISUALLY INSPECT THE DEVICE WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF A DEVICE ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE AS THE DEVICE WAS USED IN THE LIVER WHICH WOULD BE CONSIDERED OFF LABEL USE. OFF LABEL USE COMPLAINTS ARE CONSIDERED TO BE UNFORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD BE ATTRIBUTED TO OFF-LABEL USE AS THE DEVICE WAS USED IN THE LIVER WHICH WOULD BE CONSIDERED OFF LABEL USE AS PER IFU THIS DEVICE IS USED "TO DIRECTLY MEASURE PRESSURES IN THE HEPATIC AND PORTAL VENOUS VASCULATURES AND IS USED IN CONJUNCTION WITH AN ULTRASOUND ENDOSCOPE." SUMMARY: COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    BENT NEEDLE BUT STILL COULD BE USED; NOT SATISFIED WITH QUALITY AND PERFORMANCE OF DEVICE ON (B)(6) 2022 THE PATIENT UNDERWENT ENDOSCOPIC ULTRASOUND-GUIDED PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENTS USING THE ECHOTIP INSIGHT MEASUREMENT SYSTEM WHILE UNDER GENERAL ANESTHESIA. THE PORTAL VEIN WAS ACCESSED TRANSDUODENAL. THE DIAMETER OF THE TARGET SEGMENT OF THE PORTAL VEIN MEASURED 10 MM. THE AVERAGE PORTAL VEIN MEASUREMENT WAS 21 (MMHG). THE HEPATIC VEIN ACCESS SITE WAS NOT PROVIDED. THE DIAMETER OF THE TARGET SEGMENT OF THE HEPATIC VEIN WAS NOT PROVIDED. THE AVERAGE HEPATIC VEIN (PRESSURE) MEASUREMENT WAS 11.3 (MMHG). THE FINAL ECHOTIP PORTAL PRESSURE GRADIENT MEASUREMENT WAS 10 (MMHG). ADDITIONAL PROCEDURES INCLUDED LIVER BIOPSY. PROCEDURE WAS COMPLETE AND THE PATIENT DID NOT EXPERIENCE ANY MEDICAL PROBLEMS. THIS FILE WILL CAPTURE OFF LABEL USE OF THE ECHO NEEDLE FOR LIVER BIOPSY.

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 28-DEC-2022 AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1585175 ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENT SYSTEM Endoscopic transhepatic venous access needle QIJ COOK IRELAND LTD C1875252

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female